Overweight, Obesity
Conditions
Brief summary
The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (\>=) 24 kilogram per square meter (kg/m\^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Participants will either get NNC0487-0111 or placebo. Which treatment participants will get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 60 days.
Interventions
DRUGNNC0487-0111
Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m\^2)(both inclusive), with a body weight greater than or equal to (\>=) 65.0 kilogram (kg), at screening. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: * Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 Nanograms per millilitre (ng/mL) (30 nanometer\[nM\]) at screening * Parathyroid hormone (PTH) outside normal range at screening * Total calcium outside normal range at screening * Amylase greater than or equal to (\>=) 2 times upper limit of normal at screening * Lipase greater than or equal to (\>=) 2 times upper limit of normal at screening * Calcitonin greater than or equal to (\>=) 50 picograms per milliliter (pg/mL) at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31) | Number of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24h,MD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 24 hours after last multiple dose | From pre-dose on Day 10 until Day 11 | measured in hour\*nanomoles per liter (h\*nmol/L) |
| Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose | From pre-dose on Day 10 to completion of the end-of-study visit (Day 31) | measured in nanomoles per liter(nmol/L) |
| tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose | From pre-dose on Day 10 to completion of the end-of-study visit (Day 31) | measured in hour (h) |
| Change in bodyweight | From baseline Day 1 to Day 11 | measured in percentage (%) |
| Change in fasting plasma glucose | From baseline Day 1 to Day 11 | measured in millimoles per liter (mmol/L) |
Countries
China
Outcome results
None listed